Developments – BioTuesdays

Developments

Prevail Therapeutics gets FDA fast track designation for Gaucher disease

Prevail Therapeutics’ (NASDAQ:PRVL) PR001 received FDA fast track designation for the treatment of neuronopathic Gaucher disease. Gaucher disease is a lysosomal storage disorder caused by mutations in the...

October 27, 2020

Developments

Taysha gets FDA rare pediatric and orphan drug designations for Leigh syndrome

Taysha Gene Therapies (NASDAQ:TSHA) received FDA rare pediatric and orphan drug designations for TSHA-104 for the treatment of SURF1-associated Leigh syndrome. Leigh syndrome is a severe neurological disorder that...

October 27, 2020

Developments

Imagin Medical reports agenda for KOL virtual investor event on Oct. 29

Imagin Medical (CSE:IME; OTCQB:IMEXF; Frankfurt & Stuttgart Symbol:DPD2) reported the agenda for its KOL virtual investor event taking place on Oct. 29 at 12:00 pm ET. Presenters include Jim Hutchens, Imagin’s...

October 26, 2020

Developments

Hepion to present on therapeutic approaches to COVID-19; NASH at Oct. 28; Oct. 29 events

Hepion Pharmaceuticals (NASDAQ:HEPA) will present virtually at the Roth Capital “therapeutic approaches for COVID-19” event taking place on Oct. 28 from 9:00 am to 1:20 pm ET; and at the B. Riley Securities...

October 26, 2020

Developments

Titan Pharma in debt settlement pact with Molteni and Horizon

Titan Pharmaceuticals (NASDAQ:TTNP) inked an agreement to settle all of its debt obligations with Molteni & C. dei F.lli Alitti Società di Esercizio and Horizon Credit. The debt was secured with a lien on all assets...

October 26, 2020

Developments

Kezar KZR-616 gets FDA orphan drug designations for two autoimmune disease

Kezar Life Sciences’ (NASDAQ:KZR) KZR-616 received FDA orphan drug designation for the treatment of polymyositis and dermatomyositis, autoimmune inflammatory myopathies with marked morbidity and mortality. KZR-616 is a...

October 23, 2020

Developments

PhaseBio discontinues Phase 2 COVID-19 trial

PhaseBio Pharmaceuticals (NASDAQ:PHAS) discontinued its Phase 2 trial evaluating PB1046 for the treatment of high-risk, hospitalized COVID-19 patients. PB1046 is a long-acting analog of vasoactive intestinal peptide...

October 23, 2020

Developments

BiondVax universal flu vaccine fails Phase 3 trial

A Phase 3 clinical trial of BiondVax Pharmaceuticals’ (NASDAQ:BVXV) M-001 universal flu vaccine did not demonstrate a statistically significant difference between the vaccinated and placebo groups in reduction of flu...

October 23, 2020

Developments

TG Therapeutics gets FDA fast track designation for ublituximab plus umbralisib

TG Therapeutics (NASDAQ:TGTX) received the FDA fast track designation for the ublituximab plus umbralisib for the treatment of chronic lymphocytic leukemia (CLL). Ublituximab is a glycoengineered anti-CD20 monoclonal...

October 21, 2020

Developments

Cidara updates Phase 2 rezafungin data

Cidara Therapeutics (NASDAQ:CDTX) reported new data from its Phase 2 STRIVE trial evaluating once-weekly rezafungin for the treatment of candidemia and invasive candidiasis. The trial demonstrated that rezafungin...

October 21, 2020

Developments

IntelGenx grants Tetra Bio-Pharma additional rights to Adversa mucoadhesive delivery technology

IntelGenx (TSXV:IGX; OTCQB:IGXT) granted cannabinoid-derived drug developer Tetra Bio-Pharma (TSX:TBP) (OTCQB:TBPMF) additional exclusive worldwide rights to IntelGenx’s Adversa mucoadhesive delivery technology. Adversa...

October 20, 2020

Developments

Inventiva odiparcil gets FDA fast track designation for mucopolysaccharidosis

Inventiva’s (PSE:IVA; NASDAQ:IVA) odiparcil received FDA fast track designation for the treatment of mucopolysaccharidosis (MPS) Type VI, a rare progressive genetic disorder. MPS is caused by deficient versions of the...

October 20, 2020

Developments

Aclaris doses first patient in Phase 2a atopic dermatitis trial

Aclaris Therapeutics (NASDAQ:ACRS) dosed the first patient in its Phase 2a trial evaluating ATI-1777 for the treatment of moderate-to-severe atopic dermatitis ATI-1777 is a topical Janus kinase (JAK) 1/3 inhibitor...

October 20, 2020

Developments

Evofem Biosciences enrolls first patient in Phase 3 STD prevention trial

Evofem Biosciences (NASDAQ:EVFM) enrolled the first patient in its Phase 3 trial evaluating EVO100 for the prevention of urogenital chlamydia and gonorrhea in women. The trial, called EVOGUARD, will enroll 1,730 women...

October 20, 2020

Developments

Selecta gets FDA rare pediatric disease designation for methylmalonic acidemia gene therapy

Selecta Biosciences’ (NASDAQ:SELB) MMA-101 received FDA rare pediatric disease designation for the treatment methylmalonic acidemia (MMA). MMA is caused by a mutation in the methylmalonyl-CoA mutase gene, which results...

October 20, 2020

Developments

Anavex reports positive results from Phase 2 Parkinson’s disease trial

Anavex Life Sciences (NASDAQ:AVXL) reported positive results from its Phase 2 study evaluating ANAVEX2-73 for the treatment of Parkinson’s disease dementia. The proof-of-concept study enrolled 132 patients who received...

October 15, 2020

Developments

Titan Pharma to focus on ProNeura-based product development

Titan Pharmaceuticals (NASDAQ:TTNP) reported that it will discontinue U.S. Probuphine sales and wind down commercialization activities as it restructures to focus on ProNeura-based product development. “Marketing of...

October 15, 2020

Developments

Taysha gets FDA rare pediatric and orphan drug designations for Rett syndrome

Taysha Gene Therapies (NASDAQ:TSHA) received FDA rare pediatric and orphan drug designations for TSHA-102 for the treatment of Rett syndrome. Rett syndrome is a genetic neurodevelopmental disorder characterized by...

October 14, 2020

Developments

Evelo doses first patient in Phase 2 psoriasis study

Evelo Biosciences (NASDAQ:EVLO) dosed the first patient in its Phase 2 study evaluating EDP1815 for the treatment of mild-to-moderate psoriasis. The placebo-controlled study will enroll 225 patients to evaluate three...

October 13, 2020

Developments

AnaptysBio reports positive topline data from Phase 2 pustular psoriasis trial

AnaptysBio (NASDAQ:ANAB) reported positive topline data from an interim analysis of its Phase 2 trial evaluating imsidolimab or the treatment of generalized pustular psoriasis (GPP). GPP is a rare, chronic, life...

October 13, 2020

Developments

Axovant gets FDA rare pediatric designation for gangliosidosis gene therapy

Axovant Gene Therapies (NASDAQ:AXGT) received FDA orphan drug designation for AXO-AAV-GM1 for the treatment of GM1 gangliosidosis. GM1 gangliosidosis is a progressive and fatal disease where mutations in the GLB1 gene...

October 9, 2020

Developments

Rigel Pharma enrolls first patients in Phase 2 COVID-19 trial

Rigel Pharmaceuticals (NASDAQ:RIGL) enrolled the first patients in its Phase 2 trial evaluating fostamatinib for the treatment of hospitalized COVID-19 patients. The study is sponsored by the NIH’s National Heart, Lung...

October 9, 2020

Prevail Therapeutics gets FDA fast track designation for Gaucher disease

Taysha gets FDA rare pediatric and orphan drug designations for Leigh syndrome

Imagin Medical reports agenda for KOL virtual investor event on Oct. 29

Hepion to present on therapeutic approaches to COVID-19; NASH at Oct. 28; Oct. 29 events

Titan Pharma in debt settlement pact with Molteni and Horizon

Kezar KZR-616 gets FDA orphan drug designations for two autoimmune disease

PhaseBio discontinues Phase 2 COVID-19 trial

BiondVax universal flu vaccine fails Phase 3 trial

TG Therapeutics gets FDA fast track designation for ublituximab plus umbralisib

Cidara updates Phase 2 rezafungin data

IntelGenx grants Tetra Bio-Pharma additional rights to Adversa mucoadhesive delivery technology

Inventiva odiparcil gets FDA fast track designation for mucopolysaccharidosis

Aclaris doses first patient in Phase 2a atopic dermatitis trial

Evofem Biosciences enrolls first patient in Phase 3 STD prevention trial

Selecta gets FDA rare pediatric disease designation for methylmalonic acidemia gene therapy

Anavex reports positive results from Phase 2 Parkinson’s disease trial

Titan Pharma to focus on ProNeura-based product development

Taysha gets FDA rare pediatric and orphan drug designations for Rett syndrome

Evelo doses first patient in Phase 2 psoriasis study

AnaptysBio reports positive topline data from Phase 2 pustular psoriasis trial

Axovant gets FDA rare pediatric designation for gangliosidosis gene therapy

Rigel Pharma enrolls first patients in Phase 2 COVID-19 trial

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